About this trial
Whole-body magnetic resonance imaging (WB-MRI) is a non-ionizing imaging method that can provide WB coverage using essential imaging contrasts with the possibility to include sequences focusing in specific body-regions as needed per case. WB-MRI is increasingly being used for the management of cancer patients, especially metastatic ones. An integral part of WB-MRI is becoming whole-body diffusion-weighted MRI (WB-DWI) which is a non-invasive tool used for staging and response evaluation in oncologic practice. WB-DWI is an inherently noisy technique, resulting in it accounting for more than 50% of the acquisition time of conventional whole-body MRI studies with overall duration at least 1-hour. Reducing acquisition times, without compromising image or diagnostic quality would facilitate the wider adoption of clinical WBDWI, reducing costs, and improving the patient experience
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old;
Patients with diagnosis of multiple myeloma, lymphoma, lung, prostate, breast, colorectal and gynecologic cancers;
Patients with genetic syndromes responsible for an increased predisposition to neoplasms (e.g. Li Fraumeni syndrome);
Signed written informed consent to personal data treatment for research purposes
Disqualifiers
Age <18 years old;
Refusal to sign the written informed consent to personal data treatment for research purposes.
Trial population
Oncologic patients (with multiple myeloma, lymphoma, melanoma and metastatic cancer, such as prostate, breast and gynecologic cancers. Another application of WB-MRI is the imaging of patients with certain cancer predisposition syndromes
Trial design
Other
Prospective
Treatments tested in this trial
Enhanced Diffusion Software
DeviceApplication of specific sequences with the use of Enhanced Diffusion Software during Patient MRI
Treatment groups
Trial outcomes
Primary outcomes
Radiologists' satisfaction of the quality of images
Radiologists' satisfaction of the quality of images after applying noise reduction methods, in terms of mean overall response rate ≥4 at the questionnaires' items
Secondary outcomes
Diagnostic accuracy of the de-noised WB-MRI in detecting lesions
Comparison of diagnostic accuracy for lesion detection after applying noise reduction methods with that of standard reference imaging modalities,
Diagnostic accuracy of the de-noised WB-MRI in detecting staging metastatic oncologic patients.
Comparison of diagnostic accuracy for staging neoplasms according to the reference staging system with that of standard reference imaging modalities.
Sponsors and contacts
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
GE Healthcare
Collaborator
This trial is not recruiting at the moment. You can still explore other options: